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Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372500
Recruitment Status : Unknown
Verified February 2015 by Dale Vimalachandran, Countess of Chester NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Dale Vimalachandran, Countess of Chester NHS Foundation Trust

Brief Summary:
It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Surgery Dietary Supplement: Chewing gum Not Applicable

Detailed Description:

Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.

The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).

The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Chewing gum
Patients will chew sugar free gum three times a day
Dietary Supplement: Chewing gum
Sugar free chewing gum

No Intervention: Control
Normal post operative care



Primary Outcome Measures :
  1. Bowel function (as assessed by questionnaire) [ Time Frame: Minutes (end of surgery to first passage of flatus, measured up to 4 weeks) ]
    Time to passage of flatus


Secondary Outcome Measures :
  1. Diet (as assessed by questionnaire) [ Time Frame: Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation) ]
    Time to tolerating full diet

  2. Length of stay [ Time Frame: Days (till successful discharge from secondary care to home or respite care measured up to first 31 days) ]
  3. Post op nausea and vomiting score (as recorded by visual analogue scale) [ Time Frame: Recorded daily for first 5 days ]
    Post op nausea and vomiting score (PONV)

  4. Morbidity [ Time Frame: Days (recorded up to 30 days and defined by Clavien-Dindo scale) ]
    Post operative morbidity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent

Exclusion Criteria:

  • Emergency colorectal surgery, unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372500


Contacts
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Contact: Dale Vimalachandran, MD FRCS 4401244365475 dale.vimalachandran@nhs.net
Contact: Sheila Williams sheila.williams4@nhs.net

Locations
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United Kingdom
Countess of Chester Hospital
Chester, Cheshire, United Kingdom, CH2 1UL
Sponsors and Collaborators
Countess of Chester NHS Foundation Trust
Investigators
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Study Director: Dale Vimalachandran, MD FRCS Countess of Chester
Principal Investigator: Rachel Clifford, MRCS Countess of Chester
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Responsible Party: Dale Vimalachandran, Consultant Colorectal Surgeon, Countess of Chester NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02372500    
Other Study ID Numbers: Surg050/14
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases